Phase
Condition
Sleep Apnea Syndromes
Dementia
Mild Cognitive Impairment
Treatment
Positive airway pressure
Oral appliance therapy
Positional therapy
Clinical Study ID
Ages 55-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Cognitively normal (TiCS ≥29)
Age 55-85 years
Moderate - severe OSA defined as AHI4 ≥20 events/hour or AHI3A>40/hr using ahypopnea criterion of a 4% oxygen desaturation (AHI4) or 3% oxygen desaturationand/or EEG arousal (AHI3A), or equivalent based on in-home testing - Testing musthave been completed in past 12 months or confirmed by repeat test (EHR)
Not currently on therapy for OSA and has not received treatment for OSA for at least 6months
Able and willing to be treated for OSA (Treatment group)
Fluency in English or Spanish
Exclusion
Exclusion Criteria:
Documented diagnosis of chronic insomnia, or sleep onset insomnia based on InsomniaSeverity Index
Documented diagnosis of circadian rhythm disorder
Any current use of supplemental oxygen
Other sleep-related breathing disorders (central sleep apnea, etc) based on AASMcriteria
Current shift work involving night shift (regular work between 12am and 6am or nightshift) within the past 6 mo
Anticipated scheduled bariatric surgery within the next 3 months
Chronic regular (> 2 nights per week) of cannabis for sleep
Diagnosis of uncontrolled psychiatric disease in the last six months , and/orhistory of schizophrenia or bipolar disorder. Controlled conditions will includemajor depressive disorder, panic disorder, generalized anxiety disorder, OCD,substance use disorders, and alcohol abuse/dependence. (medical record/EHR).Personality disorders and neurodevelopmental disorders (e.g. autism, ADHD) areallowed if cognition is within normal limits.
Taking methylphenidate for ADHD. Unless on stable dose which will be reviewed by thePI to determine.
Taking GLP-1 agonist semaglutide (Ozempic, Wegovy, Rybelsus), or tirzepatide (Mounjaro, Zepbound), or similar for weightloss, and planning to lose an additional 20lbs or more at the time of enrollment. (Screening form/Electronic Medical Record)PI Discretion for determination of why they are taking the drug based onconversation with subject and medical chart, will be documented in form ofNote-to-file in the subject's records
Presence of other critical comorbid conditions that would lead to inability tocomplete the study protocol (including follow-up for 2 years), or that would affectcognition (e.g. clinically relevant endocrine or hematological conditions). (PerSITE PI)
Does not have a regular sleeping environment (i.e., sleeps in a different setting > 2 nights per week).
Currently pregnant or planning to become pregnant.
Prior diagnosis of a Central nervous system (CNS) disease, such as multiplesclerosis, stroke, Parkinson's disease, Alzheimer's disease, epilepsy, a loss ofconsciousness > 24 hours, or traumatic brain injury as identified by the CumulativeIllness Rating Scale for Geriatrics (CIRS). Participants who are diagnosed with MCIor Alzheimer's disease based on neuropsychological testing will be excluded. (CLINICRECORDS/EHR). Delirium in the last 12 months.
Near-miss or prior automobile accident "due to sleepiness" within the past 12months.
Employed as a commercial driver during the study (for example, bus drivers, trainengineers, airplane pilots).
Any use of neuroleptics, benzodiazepines, barbiturates, opiates or anti-amyloidtherapies.
Use of other cognitive enhancing drugs will also be excluded if initiated in thelast 3 months, or not on stable dose.
Consumption of >14 alcohol drinks per week, unless alcohol consumption can bereduced if initiated in the last 3 months
Study Design
Study Description
Connect with a study center
University of Arizona
Tucson, Arizona 85719
United StatesActive - Recruiting
Mount Sinai
New York, New York 10023
United StatesActive - Recruiting
New York University
New York, New York 10016
United StatesActive - Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
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